SFDA Medical Device Registration (MDMA)

Medical devices in Saudi Arabia must obtain approval from the Saudi Food and Drug Authority (SFDA). This is achievable through the Medical Device Marketing Authorization (MDMA) application. In this post, we explain the laws and regulations governing the medical device products and establishments.

Introduction

The SFDA is a member of the International Medical Device Regulators Forum (IMDRF). It regulates medical device products and establishments in the Kingdom of Saudi Arabia. The products must receive a Medical Device Marketing Authorization (MDMA).

Once granted, manufacturers must comply with the post-marketing obligations, including safety reporting, Unique Device Identification (UDI), and other life cycle management processes.

Application Types

There were previously several types of SFDA medical device applications for registration. However, most are now sunsetted. The authority unified all into one route, the MDMA application.

MDNR (Low Risk) – Cancelled

Companies used to register Non-sterile, non-measuring, Low-Risk Medical Devices through the Medical Device National Registry (MDNR), also known as “Medical Devices Listing,” which is exempt from MDMA and AR. However, in September 2022, the SFDA cancelled the MDNR procedure. Therefore, all devices must have a technical file for MDMA with an appointed AR in Saudi Arabia.

MDMA 1 (GHTF) – Cancelled

In this application route, the SFDA considered approvals from GHTF member countries, including the European Union, the United States, Canada, Australia, and Japan. It was an easy route to follow without deep technical inquiries. However, by the end of 2021, the SFDA had cancelled this GHTF route.

MDMA 2 (TFA) – Active

From January 2022, MDMA2 became the only option for all medical devices and in vitro diagnostics (IVDs). It requires the submission of a complete Technical File Application (TFA), and the CE is not required.

Registration Requirements

The requirements vary according to the product type and class. Here are a few examples:

• Administrative & Product Identification
  • Device Classification
  • Device Label and Packaging Information
• Safety, Risk & Performance Documentation
  • Essential Principles (EP List) of Safety & Performance
  • Benefit-risk analysis
  • Risk Management File (Plan & Report)
  • Preclinical testing data
  • Biocompatibility Test Reports.
  • Electrical Safety, EMC, Software validation (as applicable)
  • Sterilisation and Shelf-Life Validation (if sterile)
• Clinical Evaluation & Surveillance
  • Clinical investigation plan, and Clinical Evaluation Report (CER)
  • Post Market Clinical Follow Up (PMCF), Post Market Surveillance (PMS), and Periodic Safety Update Report (PSUR).

Download the complete list: MDMA Checklist

Registration Process

Classification

Applicants must classify their products according to the SFDA rules within the MDMA application. These rules correspond to the EU regulation (CE certificate). In the sections below, we list the risk classes classifications in Saudi Arabia for both devices and IVDs.

Medical Device Classes

SFDA medical device classification is either Class A, B, C, or D, based on the risk class. The class is necessary to determine the registration procedure and its requirements, as discussed in the table below:

SFDA Classification	Risk Class	MDR Classification Rule
Class A	Low	I
Class A – Sterile	Low-medium	Is
Class A – Measuring function	Low-medium	Im
Class A – Reusable surgical instruments	Low-medium	Ir
Class B	Low-medium	IIa
Class C	Medium-high	IIb
Class D	High	III

Classification is according to the following:

• Intended use.
• Risk level (harm probability and severity to the patients, users, and others).
• Nature of the device on or within the human body (e.g., invasive)
• Use duration (transient, short-term, long-term)

Identical devices could be classified differently according to the targeted body part or clinical setting. Therefore, the intended use is crucial in determining the correct classification. The intended use reference is reflected in the following:

• Instructions for Use (IFU)
• Label
• Promotional materials
• Technical File

In Vitro Diagnostics (IVDs) Classes

For in vitro diagnostic medical devices, the SFDA employs a risk-based classification system that is broadly aligned with the International Medical Device Regulators Forum (IMDRF) principles and is similar in structure to the EU IVDR, although it is applied independently.

SFDA IVD Classification	Risk Class	Classification Rule
Class A	Low individual risk and low public health risk	A
Class B	Moderate individual risk and/or low public health risk	B
Class C	High individual risk and/or moderate public health risk	C
Class D	High individual risk and high public health risk	D

The applicant is responsible for determining the class of the IVD by:

• Applying the classification rules for IVD medical devices, and
• Considering:
  • Intended use
  • Level of risk

Bundling Multiple Devices

Grouping multiple devices in the same application is permissible; the applicant may bundle up to 50 items in one MDMA application. However, products must meet several conditions, such as having the same legal manufacturer, the same risk class, and the same intended use.

Bundling Type	Criteria	Examples
Single Product	A device sold in multiple sizes or models with the same intended use	Syringes with different volumes
Family	Devices with the same risk class, manufacturer, design, and intended use	Catheters of varying lengths
System	Devices intended to operate together for a common purpose	ECG machine + electrodes + leads
Set	Devices packaged together and intended for a common medical purpose	Surgical kits or dental kits
Software Suite	Related software modules that work as part of the same platform	Hospital management or imaging analysis software
IVD’s	Can be bundled in case of the same risk class, manufacturer, design, and intended use	Blood collection tubes, Culture media

Timelines

The assessment timelines vary according to several factors, including risk class, product complexity, the number of bundled products, and the completeness of the file. Unidentified gaps before the submission may delay the approval. The entire timeline for the registration project includes:

• Gap Analysis Time
  This part depends on the number and type of gaps, the speed of manufacturer feedback, and the regulatory staff’s experience.
• SFDA Assessment Time
  For the official review timelines, refer to our article SFDA timelines.

Fees

The MDMA application fees vary according to the medical device risk Class and the number of products in the application. For more information, refer to our updated SFDA Fees post.

Renewal

MDMA’s default validity is three years. Manufacturers can submit an MDMA renewal application up to three months (90 days) before the expiration date.

Update

To make changes to the registered medical device, manufacturers must submit an MDMA update application.

MDMA Certificate

SFDA will issue an MDMA certificate in both Arabic and English containing the following:

• The manufacturer’s information (License Holder)
• Medical Device Name and Medical Device Group Information.
• Validity Period
• Certificate number

Product Categories

Here are examples of medical device types and categories in Saudi Arabia:

• Diagnostic Devices:
  • Imaging Equipment: X-ray machines, CT scanners.
  • Monitoring Devices: ECG machines and blood pressure monitors.
  • In Vitro Diagnostic Devices: Pregnancy tests, blood glucose meters.
• Therapeutic Devices:
  • Respiratory Devices: Ventilators, nebulisers.
  • Infusion Devices: Insulin pumps and IV therapy equipment.
  • Rehabilitation Devices: Wheelchairs, prosthetics.
• Implantable Devices:
  • Cardiovascular Devices: Pacemakers, stents.
  • Orthopaedic Implants: Hip replacements, spinal rods, joint replacements.
• Surgical Instruments:
  • Cutting Instruments: Scalpels, surgical scissors, forceps.
  • Staplers and Sutures: Surgical staplers, absorbable sutures.
• Dental Devices:
  • Restorative Materials: Dental crowns, fillings.
  • Orthodontic Appliances: Braces, retainers.
  • Other: dental drills
• Ophthalmic Devices:
  • Corrective Lenses: Contact lenses, eyeglasses.
  • Surgical Equipment: LASIK machines, intraocular lenses.
• Medical Software (SaMD):
  • Diagnostic Software: AI for image analysis.
  • Treatment Planning Software: Radiation therapy planning tools.
• Laboratory Equipment:
  • Analyzers: Blood gas analyzers and hematology analyzers.
  • Sterilisation equipment: Autoclaves, UV sterilisers.
• Medical Gases
• Home Healthcare Devices:
  • Monitoring Devices: Blood glucose monitors and digital thermometers.
  • Mobility Aids: Walkers, electric scooters.
• Therapeutic devices (e.g., dialysis machines)

Medical Device Importing License (MDIL)

Importing medical devices requires a valid MDMA. However, the SFDA may exempt some medical devices from registration and only require them to issue a medical device importing license (MDIL). For example:

• Demonstration or training purposes, medical devices.
• Chemicals (finished products), whether classified as medical devices or used in conjunction with medical devices (e.g., gases used to calibrate medical devices, as well as chemicals used to ensure the sterilisation operation of medical devices, the manufacturing of prostheses, and the preservation of tissues or cells). Excluding the following products:
  • Radioactive materials
  • Medical IVD
  • Non-medical IVD
  • Chemical precursors.
• The distillation apparatuses for healthcare providers or educational facilities.
• Research and Educational use products.
• Semi-finished medical devices/supplies (and raw and non-raw chemicals) for local manufacturing (manufacturing includes refurbishing, assembling, packaging, and labelling).

Whether your company is new to the Saudi market or already established, PharmaKnowl will help you comply with the SFDA and facilitate your business by providing compliance, insights, and supply management to your distributors, all without requiring shipment commissions.

PharmaKnowl is an SFDA-licensed service provider in Saudi Arabia representing well-known international companies. Contact us to schedule an exploratory meeting or request more information.

Frequently Asked Questions